CAPA reports are critical in every regulatory inspection for medical devices, pharmaceuticals, and other life science companies worldwide including the EU and the US. They must be accurately written and should provide the auditors the information about the CAPA sub-system in the company.
A poorly written CAPA report can result in a warning letter from the FDA, no matter how well the CAPA sub-system was executed. Similarly, International Organization for Standardization – ISO also requires Corrective and Preventive action reports during their routine audits. It may issue non-conformance if a company fails to provide properly written CAPA reports.
The auditors review the CAPA reports in knowing the organization’s ability to understand non-conformance and whether the organization has taken enough measures to correct and prevent the non-conformance.
In this article, you will learn about the importance of CAPA report and how to write an effective report that conforms to the regulatory requirements. It also includes an example CAPA report to help you prepare your own.
But first, let’s cover the basics:
- What Is a Corrective and Preventive Action (CAPA) Report
- When Is Corrective and Preventive Action (CAPA) Report Required?
- How Do You Write a Corrective and Preventive Action (CAPA) Report?
- Corrective and Preventive Action (CAPA) Report Example
- CAPA Report Form Template [Free Download]
- Digitize and Automate CAPA Reporting Processes
What Is a Corrective and Preventive Action (CAPA) Report
A CAPA report is documented evidence that a CAPA system has been successfully implemented.
It summarizes the entire CAPA activity, with detailed identification and description of non-conformance. It also includes the corresponding Corrective and Preventive measures for that particular non-conformance.
A CAPA report and CAPA form are essentially the same things. When personnel fills the CAPA form with the relevant data and subsequent approval by authorized personnel, the CAPA form’s status changes to the CAPA report.
A well-written CAPA report demonstrates that the organization has an effective quality system in place. The quality system is well equipped with the necessary tools, personnel expertise, and resources, which helps identify problems. It also implements corrective and preventive actions to tackle the quality problems.
If, for example, a lack of training is identified as Preventive Action, the report contains information about the training contents, trainer, training participants, and training evaluation plan for the trainees.
Regulatory bodies have no compulsion to include corrective and preventive action in the same report. Instead, it leaves the decision to the organization.
Some organizations include Corrective and Preventive in one report, often called Corrective and Preventive Action (CAPA) reports. Meanwhile, others have Corrective and Preventive in a separate report, called Corrective Action Report (CAR) and Preventive Action Report (PAR).
More and more life science companies are utilizing software solutions, including the CAPA software to generate the CAPA reports. Learn how the SimplerQMS CAPA management software module can automate your CAPA reporting processes.
When Is Corrective and Preventive Action (CAPA) Report Required?
Not every event requires a CAPA report. Instead, it depends on the problem’s severity. The quality department should evaluate the problem’s impact in terms of risk severity in a Risk Assessment stage to determine whether corrective and preventive actions are required or not.
Assessing the risk severity also enables the quality department to determine the risk impact, resource allocation, investigation level required and evaluate corrective and preventive actions.
For example, injury or illness caused by a product is a severe issue. The CAPA for this issue is necessary, and a subsequent CAPA report is also created.
Another example could be a complaint indicating the absence of labels inside a pack for various batches. Since this problem is recurring, and can adversely affect the product and user, CAPA for this problem is necessary. The report is also created defining necessary corrective and preventive actions.
How Do You Write a Corrective and Preventive Action (CAPA) Report?
As mentioned above, the CAPA report is the CAPA form’s filled version.
Each field represents a synchronized activity and must be filled properly.
Following are some common steps to fill the CAPA form, which then takes the status of the CAPA report.
CAPA Initiation
As mentioned before, not every quality issue requires a CAPA, so accurately determining the CAPA’s Initiation is very crucial. The quality department initiates the CAPA activity by assigning and filling out a CAPA form.
Different organizations can create their CAPA forms, and their creation depends on several factors.
Common data fields necessary to the CAPA form include:
- Problem Description
- Source of problem
- Date, time, and location of quality problem detected
- Personnel / department
- Is the CAPA related to process or product
For example, the quality department receives the complaint of expiry date misprinting. In this case, the quality department will first decide whether it requires a CAPA or not?
Free Resource: Corrective and Preventive Action (CAPA) Form Template
CAPA Team
The quality department forms a team to conduct a CAPA investigation. The team should include experts from all the relevant departments. They must be informed and briefed about their responsibilities and roles.
For example, for a wrong expiry date printing problem, possible departmental representatives can include Production, Quality, and Engineering.
In an eQMS System assign responsibilities for CAPA tasks or actions to specific employees on your team. This means that one employee handles the Root Cause Analysis and another person is responsible for the Verification. Learn how the CAPA management software module by SimplerQMS can help you work more efficiently with your CAPA process.
Root Cause Analysis
Root Cause Analysis is critical in determining preventive action selection. The potential causes can be identified without classifying them into different categories in this stage.
For example, what were the causes of wrong printing on the packs? Was the operator aware of malfunctioning? Was the operator capable enough to operate the printing equipment? Were the quality personnel deployed on the floor present at the time of the problem?
Risk Assessment
In this step, the problem severity is determined and how it impacts the organization and customers.
Corrective and Preventive Actions
The corrective actions are immediately required to solve the problems in the process. It makes sure that the process returns to normal working parameters. Corrective actions are often implemented before the Root Cause Analysis stage.
Preventive actions are implemented to prevent the problem recurrence and promote continuous improvement – the primary purpose of the CAPA system.
Planning
The planning for implementing corrective and preventive actions is performed. It involves assigning roles and responsibilities, due dates, and allocating resources.
Verification and Documentation
After identifying the corrective and preventive actions, these are once again evaluated for process improvement. It also monitors the effectiveness of corrective and preventive measures.
Closing
The CAPA form is filled along with the activity after satisfactory results of Corrective and Preventive Actions.
At this stage, the form takes the status of the report. The CAPA report is verified and approved with relevant personnel with their signatures.
Corrective and Preventive Action (CAPA) Report Example
Let’s give an example of a CAPA report.
The internal audit has found out that the manufacturing process in a pharmaceutical factory is being executed without proper manufacturing documents. The factory implements only a manufacturing checklist without critical process data recording.
Lack of critical data and process recording is a severe non-conformity, and regulatory bodies require a CAPA for this non-conformity. The quality department has issued a CAPA for it, and we will see how the CAPA form is filled along the way, which then takes the form of a CAPA report.
Description of an Issue
The organization failed to produce batch production records, including manufacturing, processing, and packing information.
Scope
The CAPA is related to the process.
Root Cause Analysis
The organization used a manufacturing checklist without instructions, not recording proper manufacturing information.
Risk Assessment
The nature of this problem is critical, and it can seriously impact the product.
It lacks essential manufacturing data such as batch ingredients, mixing time, and temperature. It also lacks critical data to investigate batch failures.
Immediate Correction
Since this is a critical issue, the quality department immediately stops product manufacturing.
The quality department with the production department points out all the relevant data parameters required in manufacturing. It also takes guidelines from regulatory regulations and personnel expertise.
Corrective Action/Preventive Action
A joint team is created consisting of the Quality and Production department.
The team consults different regulatory guidelines such as cGMP (Current Good Manufacturing Practice) and uses personnel expertise to identify missing manufacturing information.
In addition, the formed team:
- Reviews the current documentation practices
- Updates all documentation related to all products
- Revises SOPs in line with cGMP requirements
- Sets out the deadlines for the implementation of the proposed action plan
Verification of Corrective/Preventive Action
After the due date for Corrective and Preventive Action implementation has passed, the CAPA team again reviews the documentation.
It is considered complete if the revised documentation includes each manufacturing step information. The CAPA form is completed with all the relevant approvals and signatures.
In an eQMS, all of the relevant approvals can be routed through an automated workflow and electronic Part 11 Compliant signatures can be captured. See how electronic signatures and automated workflows work in SimplerQMS.
CAPA Report Form Template [Free Download]
Manufacturers often find it challenging to prepare their CAPA form according to regulatory requirements. These regulatory bodies require a comprehensive form that addresses every non-conformity in a pharmaceutical, medical device, or any other life science company.
At SimplerQMS, we have prepared a free CAPA report form template that could solve the problems of life science professionals. This form identifies, addresses, and prevents the occurrence of non-conformances.
You can download a free copy of a CAPA form template that will help you create a CAPA report and ensure regulatory compliance.
Digitize and Automate CAPA Reporting Processes
Manual paper-based systems pose various problems such as conflicting data, version miss-match, de-centralized data collection, communication gaps, which could deteriorate the CAPA process.
SimplerQMS provides an integrated quality management system software solution for life sciences with a built-in CAPA management software module that digitizes and automates your CAPA process. It automatically notifies the concerned person when they are assigned tasks to them.
The system allows you to easily record non-nonconformances, automate data input and follow-ups until the CAPA is marked closed. After closing, it initiates automatic approvals with the required electronic signatures.
Final Thoughts
CAPA report is the crux of the CAPA sub-system, and the regulatory bodies rely on the CAPA report to judge the company’s CAPA implementation and its effectiveness.
Regulatory bodies have no compulsions to use software solutions, but paper-based systems are proving a daunting option nowadays. They can end up more efforts with little output.
CAPA management software such as SimplerQMS is an excellent option to keep your pace with the increased competition, advanced regulatory requirements, and increased production costs.
If you would like to learn more about how SimplerQMS can help you streamline your CAPA process, we recommend you book a demo and talk to our experts.
